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274 results on '"Bouchard, Céline"'

1. Pooled efficacy results of estetrol/drospirenone combined oral contraception phase 3 trials

Author

Jensen, Jeffrey T, Kaunitz, Andrew M, Achilles, Sharon L, Zatik, János, Weyers, Steven, Piltonen, Terhi, Suturina, Larisa, Apolikhina, Inna, Bouchard, Céline, Chen, Melissa J, Apter, Dan, Jost, Maud, Foidart, Jean-Michel, and Creinin, Mitchell D

Subjects
Reproductive Medicine, Biomedical and Clinical Sciences, Clinical Trials and Supportive Activities, Pediatric, Clinical Research, Prevention, Contraception/Reproduction, Good Health and Well Being, Humans, Pregnancy, Female, United States, Adolescent, Young Adult, Adult, Estetrol, Androstenes, Contraceptives, Oral, Combined, Contraception, Estrogens, Combined oral contraception, Contraceptive efficacy, Drospirenone, E4, Native estrogen, Pearl Index, Clinical Sciences, Paediatrics and Reproductive Medicine, Public Health and Health Services, Obstetrics & Reproductive Medicine, Clinical sciences, Reproductive medicine, Health services and systems
Abstract

ObjectiveTo evaluate overall and subgroup efficacy of an estetrol (E4) 15 mg drospirenone (DRSP) 3 mg oral contraceptive in a 24/4-day regimen.Study designWe pooled efficacy outcomes from 2 pivotal phase 3 contraceptive trials with E4/DRSP conducted in the United States/Canada and Europe/Russia. We assessed Pearl Index (PI; pregnancies per 100 participant-years) and 13-cycle life-table pregnancy rates in at-risk cycles (confirmed intercourse and no other contraceptive use) among participants 16 to 35 years. We calculated PI by age and further subcategorization (contraceptive history and body mass index [BMI]). We performed multivariable analysis using Cox regression to assess impact of potential confounding factors.ResultsAnalyses included 3027 participants, of whom 451 (14.9%) had a BMI ≥30 kg/m2. The pooled PI was 1.52 (95% confidence interval 1.04-2.16) and the 13-cycle life-table pregnancy rate was 1.28% (0.83%-1.73%). We calculated unadjusted pooled PI in participants 16 to 25 years and 26 to 35 years of 1.61 (0.94-2.57) and 1.43 (0.78-2.40), respectively; in new starters and switchers of 1.88 (1.09-3.00) and 1.24 (0.68-2.08), respectively; and by BMI

Published
2022

2. Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results

Author

Creinin, Mitchell D, Westhoff, Carolyn L, Bouchard, Céline, Chen, Melissa J, Jensen, Jeffrey T, Kaunitz, Andrew M, Achilles, Sharon L, Foidart, Jean-Michel, and Archer, David F

Subjects
Hematology, Clinical Research, Clinical Trials and Supportive Activities, Patient Safety, Prevention, Contraception/Reproduction, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Reproductive health and childbirth, Androstenes, Contraceptives, Oral, Combined, Estetrol, Estrogens, Ethinyl Estradiol, Female, Humans, North America, Pregnancy, Drospirenone, Oral contraceptive, Pearl index, Clinical Sciences, Paediatrics and Reproductive Medicine, Public Health and Health Services, Obstetrics & Reproductive Medicine
Abstract

ObjectiveTo assess efficacy, cycle control, and safety of an oral contraceptive containing estetrol (E4) 15 mg and drospirenone (DRSP) 3 mg.Study designWomen aged 16 to 50 years with a body mass index ≤35 kg/m2 enrolled in this multicenter, open-label, 13-cycle, phase 3 trial evaluating E4/DRSP in a 24-active/4-placebo regimen. Follow-up was scheduled at Cycles 2, 4, 7, and 10 and within 3 weeks of completing Cycle 13. Participants used daily diaries to record pill use and vaginal bleeding. We evaluated efficacy outcomes in women 16 to 35 years and bleeding patterns and safety (adverse events [AEs]) in all participants. We assessed overall and method-failure pregnancy rates using the Pearl index (PI) and life-table analysis. Scheduled bleeding included spotting or bleeding starting during the 4-day placebo period or first 3 days of the next cycle.ResultsWe enrolled 1864 women of whom 1674 were 16 to 35 years. Women 16 to 35 years had a PI of 2.65 (95% CI 1.73-3.88), method-failure PI of 1.43 (95% CI 0.7-2.39) and 13-cycle life-table pregnancy rate of 2.1%. Scheduled bleeding occurred in 82.9% to 87.0% of women per cycle; median duration was 4.5 days. Unscheduled bleeding decreased from 30.3% in Cycle 1 to 21.3% to 22.1% during Cycles 2 to 4 and remained stable (15.5% to 19.2%) thereafter. The most frequently reported AEs were headache (5.0%) and metrorrhagia (4.6%). One-hundred thirty-two (7.1%) women discontinued the study early for an AE, most commonly for metrorrhagia (0.9%) and menorrhagia (0.8%). No thromboembolic events occurred.ConclusionE4/DRSP is an effective oral contraceptive with a predictable bleeding pattern for most women and low AE rates.Implications statementA new oral contraceptive with a novel estrogen, estetrol, combined with drospirenone has efficacy and safety within the range of other available oral contraceptives. Large phase 4 studies will be needed to confirm if this combination is associated with an improved adverse event profile or lower thrombosis risk.

Published
2021

6. International Anal Neoplasia Society Guidelines for the Practice of Digital Anal Rectal Examination.

Author

Hillman, Richard John, Berry-Lawhorn, J Michael, Ong, Jason J, Cuming, Tamzin, Nathan, Mayura, Goldstone, Stephen, Richel, Olivier, Barrosso, Luis F, Darragh, Teresa M, Law, Carmella, Bouchard, Céline, Stier, Elizabeth A, Palefsky, Joel M, Jay, Naomi, and International Anal Neoplasia Society

Subjects
International Anal Neoplasia Society, Humans, Anus Neoplasms, Diagnostic Tests, Routine, Early Diagnosis, Image Processing, Computer-Assisted, Quality Assurance, Health Care, Practice Guidelines as Topic, Optical Imaging, Obstetrics & Reproductive Medicine, Clinical Sciences
Abstract

OBJECTIVE:The aim of the study was to develop recommended techniques and quality assurance metrics for the practice of Digital Anal Rectal Examination (DARE). MATERIALS AND METHODS:The International Anal Neoplasia Society undertook a literature review and, using the AGREE II technique, developed guidelines for performing DARE. RESULTS:A consensus was formed regarding the optimum conditions and characteristics of DARE. Several Quality Assurance metrics were developed. CONCLUSIONS:Digital Anal Rectal Examination is a cheap and potentially universally available technique, which has the potential to facilitate the early diagnosis of anal cancers, when they are most amenable to treatment. These guidelines provide a basis for teaching the technique and may be used as for evaluation research.

Published
2019

7. Effects of E4/DRSP on self-reported physical and emotional premenstrual and menstrual symptoms: data from the phase 3 clinical trial in Europe and Russia.

Author

Bitzer, Johannes, Bouchard, Céline, Zatik, János, Weyers, Steven, Piltonen, Terhi, Suturina, Larisa, Apolikhina, Inna, Gemzell-Danielsson, Kristina, Jost, Maud, Creinin, Mitchell D., and Foidart, Jean-Michel

Subjects
*CLINICAL trials, *MENSTRUATION disorders, *AFFECT (Psychology), *SYMPTOMS, *END of treatment, *FATIGUE (Physiology)
Abstract

To describe the effects of estetrol (E4) 15 mg/drospirenone (DRSP) 3 mg on physical and emotional premenstrual and menstrual symptoms. We used Menstrual Distress Questionnaire (MDQ) data from a phase-3 trial (NCT02817828) in Europe and Russia with participants (18 − 50 years) using E4/DRSP for up to 13 cycles. We assessed mean changes in MDQ-t-scores from baseline to end of treatment in premenstrual (4 days before most recent flow) and menstrual (most recent flow) scores for 4 MDQ domains in starters and switchers (use of hormonal contraception in prior 3 months) and performed a shift analysis on individual symptoms within each domain. Of 1,553 treated participants, 1,398(90.0%), including 531(38%) starters, completed both MDQs. Starters reported improvements for premenstrual Pain (−1.4), Water Retention (−3.3) and Negative Affect (−2.5); and for menstrual Pain (−3.5), Water Retention (−3.4), and Negative Affect (−2.7) (all p < 0.01). For switchers, no changes were significant except an increase in premenstrual (+1.0, p = 0.02) and menstrual (+1.5, p = 0.003) Water Retention. We observed a change in symptom intensity in >40% of participants for Cramps, Backache and Fatigue (domain Pain), Painful or Tender Breast and Swelling (domain Water Retention) and Mood Swings and Irritability (domain Negative Affect). E4/DRSP starters experienced significant improvements in the domains Pain, Water Retention and Negative Affect particularly benefiting those with more severe baseline symptoms. Switchers showed minimal changes. A phase 3 study in Europe and Russia showed that Estetrol/Drospirenone, a new combined oral contraceptive, significantly improved the MDQ scores for domains Pain, Water Retention and Negative Affect in women starting COC use, while switchers showed minimal changes. [ABSTRACT FROM AUTHOR]

Published
2024
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10. 2016 IANS International Guidelines for Practice Standards in the Detection of Anal Cancer Precursors

Author

Hillman, Richard John, Cuming, Tamzin, Darragh, Teresa, Nathan, Mayura, Berry-Lawthorn, Michael, Goldstone, Stephen, Law, Carmella, Palefsky, Joel, Barroso, Luis F, Stier, Elizabeth A, Bouchard, Céline, Almada, Justine, and Jay, Naomi

Subjects
Cancer, Clinical Research, Prevention, Management of diseases and conditions, 7.3 Management and decision making, Anus Neoplasms, Humans, Precancerous Conditions, anal cancer, precursors, high-grade squamous intraepithelial lesions, anal intraepithelial neoplasia, high-resolution anoscopy, anal cytology, quality assurance, practice standards, diagnostics, Clinical Sciences, Obstetrics & Reproductive Medicine
Abstract

ObjectivesTo define minimum standards for provision of services and clinical practice in the investigation of anal cancer precursors.MethodsAfter initial face to face meetings of experts at the International Papillomavirus meeting in Lisbon, September 17 to 21, 2015, a first version was drafted and sent to key stakeholders. A complete draft was reviewed by the Board of the International Anal Neoplasia Society (IANS) and uploaded to the IANS Web site for all members to provide comments. The final draft was ratified by the IANS Board on June 22, 2016.ResultsThe essential components of a satisfactory high-resolution anoscopy (HRA) were defined. Minimum standards of service provision, basic competencies for clinicians, and standardized descriptors were established. Quality assurance metrics proposed for practitioners included a minimum of 50 HRAs per year and identifying 20 cases or more of anal high-grade squamous intraepithelial lesions (HSILs). Technically unsatisfactory anal cytological samples at first attempt in high-risk populations should occur in less than 5% of cases. Where cytological HSIL has been found, histological HSIL should be identified in ≥ 90% of cases. Duration of HRA should be less than 15 minutes in greater than 90% of cases. Problematic pain or bleeding should be systematically collected and reported by 10% or lesser of patients.ConclusionsThese guidelines propose initial minimum competencies for the clinical practice of HRA, against which professionals can judge themselves and providers can evaluate the effectiveness of training. Once standards have been agreed upon and validated, it may be possible to develop certification methods for individual practitioners and accreditation of sites.

Published
2016

20. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 7-year follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Author

Wheeler, Cosette M, Skinner, S Rachel, Del Rosario-Raymundo, M Rowena, Garland, Suzanne M, Chatterjee, Archana, Lazcano-Ponce, Eduardo, Salmerón, Jorge, McNeil, Shelly, Stapleton, Jack T, Bouchard, Céline, Martens, Mark G, Money, Deborah M, Quek, Swee Chong, Romanowski, Barbara, Vallejos, Carlos S, ter Harmsel, Bram, Prilepskaya, Vera, Fong, Kah Leng, Kitchener, Henry, Minkina, Galina, Lim, Yong Kuei Timothy, Stoney, Tanya, Chakhtoura, Nahida, Cruickshank, Margaret E, Savicheva, Alevtina, da Silva, Daniel Pereira, Ferguson, Murdo, Molijn, Anco C, Quint, Wim G V, Hardt, Karin, Descamps, Dominique, Suryakiran, Pemmaraju V, Karkada, Naveen, Geeraerts, Brecht, Dubin, Gary, and Struyf, Frank

Published
2016
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23. Efficacy, safety, and immunogenicity of the human papillomavirus 16/18 AS04-adjuvanted vaccine in women older than 25 years: 4-year interim follow-up of the phase 3, double-blind, randomised controlled VIVIANE study

Author

Skinner, S Rachel, Szarewski, Anne, Romanowski, Barbara, Garland, Suzanne M, Lazcano-Ponce, Eduardo, Salmerón, Jorge, Del Rosario-Raymundo, M Rowena, Verheijen, René H M, Quek, Swee Chong, da Silva, Daniel P, Kitchener, Henry, Fong, Kah Leng, Bouchard, Céline, Money, Deborah M, Ilancheran, Arunachalam, Cruickshank, Margaret E, Levin, Myron J, Chatterjee, Archana, Stapleton, Jack T, Martens, Mark, Quint, Wim, David, Marie-Pierre, Meric, Dorothée, Hardt, Karin, Descamps, Dominique, Geeraerts, Brecht, Struyf, Frank, and Dubin, Gary

Published
2014
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24. Lignes directrices pour ce qui est des soins à offrir aux femmes enceintes qui vivent avec le VIH et des interventions visant à atténuer la transmission périnatale : Résumé directif

Author

Yudin, Mark H., Allen, Victoria, Bouchard, Céline, Boucher, Marc, Boucoiran, Isabelle, Caddy, Sheila, Castillo, Eliana, Gottlieb, Heather, Kennedy, V. Logan, Money, Deborah, Murphy, Kellie, Ogilvie, Gina, Paquet, Caroline, van Schalkwyk, Julie, Alimenti, Ariane, Pick, Neora, and Tulloch, Karen

Published
2014
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28. Female Genital Cosmetic Surgery

Author

Leyland, Nicholas, Wolfman, Wendy, Allaire, Catherine, Awadalla, Alaa, Best, Carolyn, Dunn, Sheila, Heywood, Mark, Lemyre, Madeleine, Marcoux, Violaine, Menard, Chantal, Potestio, Frank, Rittenberg, David, Singh, Sukhbir, Shapiro, Jodi, Akhtar, Saima, Camire, Bruno, Christilaw, Jan, Corey, Julie, Nelson, Erin, Pierce, Marianne, Robertson, Deborah, Simmonds, Anne, Shaw, Dorothy, Lefebvre, Guylaine, Bouchard, Celine, Blake, Jennifer, Allen, Lisa, and Cassell, Krista

Published
2013
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34. Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy

Author

Labrie, Fernand, Derogatis, Leonard, Archer, David F., Koltun, William, Vachon, Andrée, Young, Douglas, Frenette, Louise, Portman, David, Montesino, Marlene, Côté, Isabelle, Parent, Julie, Lavoie, Lyne, Beauregard, Adam, Martel, Céline, Vaillancourt, Mario, Balser, John, Moyneur, Érick, Ackerman, Ronald T., Andruczyk, Eugene, Aqua, Keith, Archer, David F., Belle-Isle, Jasmin, Blank, Steven, Blouin, François, Bouchard, Céline, Chavoustie, Steven E., Cooper, Theodore, Cusan, Leonello, Donovan, Arthur J., Drosman, Steven, Eder, Scott E., Elfassi, Émile, Euband, Charles Dale, Fikry, Sameh, Frenette, Louise, Gervais, Benoît, Goldberg, Cynthia, Grainger, David A., Janzen, Jeannette, Koltun, William, Komer, Lawrence D., Kroll, Robin, Lederman, Samuel N., London, Andrew, McClinton, Joe D., O'Mahony, Michael FJ, O'Mahony, Williaml F., Poindexter, Alfred, III, Portman, David J., Sussman, Steven, Thériault, Guy, Upp, Linda, Vachon, Andrée, Waldbaum, Arthur, and Young, Douglas

Published
2015
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39. Relevance of omental pericellular adipose tissue collagen in the pathophysiology of human abdominal obesity and related cardiometabolic risk

Author

Laforest, Sofia, Tordjman, Joan, Pelletier, Mélissa, Michaud, Andréanne, Liu, Yuejun, Tchernof, André, Noël, Suzanne, Le Naour, Gilles, Bouchard, Céline, Clément, Karine, Laforest, Sofia, Tordjman, Joan, Pelletier, Mélissa, Michaud, Andréanne, Liu, Yuejun, Tchernof, André, Noël, Suzanne, Le Naour, Gilles, Bouchard, Céline, and Clément, Karine

Abstract

Background: Adipose tissue fibrosis is a relatively new notion and its relationship with visceral obesity and cardiometabolic alterations remains unclear, particularly in moderate obesity. Objective: Our objective was to examine if total and pericellular collagen accumulation are relevant for the pathophysiology of visceral obesity and related cardiometabolic risk. Subjects and methods: Surgical omental (OM) and subcutaneous (SC) fat samples were obtained in 56 women (age: 47.2±5.8 years; body mass index (BMI): 27.1±4.4 kg/m2). Body composition and fat distribution were measured by dual-energy X-ray absorptiometry and computed tomography, respectively. Total and pericellular collagen were measured using picrosirius red staining. CD68+ cells (total macrophages) and CD163+ cells (M2-macrophages) were identified using immunohistochemistry. Results: We found that only pericellular collagen percentage, especially in OM fat, was associated with higher BMI, body fat mass and adipose tissue areas as well as lower radiologic attenuation of visceral adipose tissue and altered cardiometabolic risk variables. Strong correlations between peri-adipocyte collagen percentage and total or M2-macrophage percentages were observed in both depots. Total collagen percentage in either compartment was not related to adiposity, fat distribution or cardiometabolic risk. Conclusions: As opposed to whole tissue-based assessments of adipose tissue fibrosis, collagen deposition around the adipocyte, especially in the OM fat compartment is related to total and regional adiposity as well as altered cardiometabolic risk profile.

Published
2020

45. Chirurgie esthétique génitale chez la femme

Author

Leyland, Nicholas, Wolfman, Wendy, Allaire, Catherine, Awadalla, Alaa, Best, Carolyn, Dunn, Sheila, Heywood, Mark, Lemyre, Madeleine, Marcoux, Violaine, Menard, Chantal, Potestio, Frank, Rittenberg, David, Singh, Sukhbir, Shapiro, Jodi, Akhtar, Saima, Camire, Bruno, Christilaw, Jan, Corey, Julie, Nelson, Erin, Pierce, Marianne, Robertson, Deborah, Simmonds, Anne, Shaw, Dorothy, Lefebvre, Guylaine, Bouchard, Céline, Blake, Jennifer, Allen, Lisa, and Cassell, Krista

Published
2013
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